# US 2026/0096779 A1 · Catheter system and methods of medical uses of same, including diagnostic and treatment uses for the heart

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- Number: US 2026/0096779 A1
- Document ID: US20260096779A1
- Status: Published application
- Kind: A1
- Application number: 19/202,319
- Filed: 2025-05-08
- Published: 2026-04-09
- Earliest claimed: 2012-08-31
- Assignees: Enchannel Medical, Ltd.
- Applicants: Enchannel Medical, Ltd.
- Inventors: Randell L. Werneth; Graydon E. Beatty; Timothy J. Corvi; J. Christopher Flaherty; Marcus Frederick Julian
- Web page: https://patentgrep.com/patent/US20260096779A1

## CPC

- A61B 5/6858: {with a distal basket, e.g. expandable basket}
- A61B 5/0036: {including treatment, e.g., using an implantable medical device, ablating, ventilating}
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/283: Invasive
- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 5/6852: {Catheters}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 8/445: {Details of catheter construction}
- A61B 8/4494: {characterised by the arrangement of the transducer elements}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 5/0538: invasively, e.g. using a catheter
- A61B 5/065: {Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe}
- A61B 5/361: Detecting fibrillation
- A61B 5/363: Detecting tachycardia or bradycardia
- A61B 5/6859: {with multiple distal splines}
- A61B 17/22012: {in direct contact with, or very close to, the obstruction or concrement (for removing obstructions in blood vessels by laser A61B18/245)}
- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 18/1815: {using microwaves}
- A61B 18/20: using laser
- A61B 2017/00318: {Steering mechanisms}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/00267: {having a basket shaped structure}
- A61B 2018/00351: {Heart}
- A61B 2018/00577: {Ablation}
- A61B 2018/00648: {using more than one sensed parameter}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes}
- A61B 2018/1465: {Deformable electrodes}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61B 2018/1475: {Electrodes retractable in or deployable from a housing}
- A61B 2034/301: {for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes}
- A61B 2562/06: Arrangements of multiple sensors of different types
- A61N 1/056: {Transvascular endocardial electrode systems}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

The present invention includes systems, devices and methods for treating and/or diagnosing a heart arrhythmia, such as atrial fibrillation. Specifically, the present invention provides a system including a diagnostic catheter and an ablation catheter. The diagnostic catheter includes a shaft, multiple dipole mapping electrodes and multiple ultrasound transducers. The ablation catheter is slidingly received by the diagnostic catheter shaft.

## Claims

### Claim 1

(canceled)

### Claim 2

A method of operating a catheter system, comprising:
providing a catheter system comprising:
a diagnostic catheter comprising:
an elongate shaft comprising a distal end;
an expandable assembly mounted to the elongate shaft, the expandable assembly comprising multiple splines and configured to transition from a compacted state to an expanded state;
a plurality of electrodes coupled to the multiple splines of the expandable assembly, each electrode configured to emit electric signals and receive electric signals; and
a plurality of ultrasound transducers coupled to the multiple splines of the expandable assembly;
a distance measurement assembly; and
a processing unit;
driving the plurality of ultrasound transducers to produce anatomical geometry data, including data representing a distance between each ultrasound transducer of the plurality of ultrasound transducers and a tissue surface orthogonal to each ultrasound transducer with the distance measurement assembly;
receiving electric signals from the plurality of electrodes;
measuring a spacing between two or more of the electrodes based on the received electric signals with the processing unit;
determining a geometric configuration of one or more of the multiple splines based on the measured electrode spacing with the processing unit;
creating a three-dimensional anatomical map based on the produced anatomical geometry data with the processing unit;
creating electrical information based on the received electric signals with the processing unit; and
displaying the electrical information in relation to the three-dimensional anatomical map with the processing unit,
wherein at least one of:
the electrical information is further based on the determined geometric configuration of the one or more of the multiple splines; and
the anatomical geometry data is based on the determined geometric configuration of the one or more of the multiple splines.

### Claim 3 (depends on 2)

The method according to claim 2, wherein:
the electrical information is based on the received electric signals and the determined geometric configuration of the one or more of the multiple splines, and
the anatomical geometry data is based on the determined geometric configuration of the one or more of the multiple splines.

### Claim 4 (depends on 2)

The method according to claim 2, further comprising determining, with the processing unit, a geometric configuration of the multiple splines based on the measured electrode spacing.

### Claim 5 (depends on 2)

The method according to claim 2, wherein the electrical information displayed comprises information selected from the group consisting of: cardiac or other tissue voltage measurements; cardiac or other tissue bipolar and/or unipolar electrograms; cardiac or other tissue surface charge data; cardiac or other tissue dipole density data; cardiac or other tissue monophasic action potentials; and combinations thereof.

### Claim 6 (depends on 2)

The method according to claim 2, further comprising deriving, with the processing unit, a shape of one or more of the multiple splines.

### Claim 7 (depends on 6)

The method according to claim 6, wherein deriving, with the processing unit, the shape of the one or more of the multiple splines is performed in real time.

### Claim 8 (depends on 2)

The method according to claim 2, further comprising deriving, with the processing unit, a relative positioning of two or more of the multiple splines.

### Claim 9 (depends on 8)

The method according to claim 8, wherein deriving, with the processing unit, the relative positioning of the two or more of the multiple splines is performed in real time.

### Claim 10 (depends on 2)

The method according to claim 2, wherein the multiple splines are resiliently biased in an equilibrium state, and the method further comprises determining, with the processing unit, a change in a shape of the multiple splines from the equilibrium state.

### Claim 11 (depends on 10)

The method according to claim 10, wherein the change in shape comprises a change in the shape of a single spline.

### Claim 12 (depends on 10)

The method according to claim 10, wherein the multiple splines comprise a first spline and a second spline, and wherein the change in shape comprises a change in the position of the first spline relative to the second spline.

### Claim 13 (depends on 10)

The method according to claim 10, wherein:
the plurality of electrodes comprises a first electrode and a second electrode,
the change in shape comprises a bowing of a first spline,
the first electrode and the second electrode are attached to the first spline, and
the bowing causes the spacing between the first electrode and the second electrode to decrease.

### Claim 14 (depends on 10)

The method according to claim 10, wherein:
the plurality of electrodes comprises a first electrode and a second electrode,
the change in shape comprises a straightening of a first spline, wherein the first electrode and the second electrode are attached to the first spline, and
the straightening causes the spacing between the first electrode and the second electrode to increase.

### Claim 15 (depends on 2)

The method according to claim 2, wherein:
the plurality of electrodes comprises a first electrode and a second electrode, and
the method further comprises applying, with a current source, a current between the first electrode and the second electrode to determine the spacing between the first electrode and the second electrode.

### Claim 16 (depends on 2)

The method according to claim 2, further comprising:
providing an ablation catheter comprising:
an elongate shaft with a distal portion; and
at least one ablation element positioned on the distal portion and configured to deliver energy to tissue,
wherein the elongate shaft of the diagnostic catheter further comprises a lumen and the method further comprises disposing at least a portion of the ablation catheter within the lumen.

### Claim 17 (depends on 16)

The method according to claim 16, wherein the at least one ablation element comprises an ablation element selected from the group consisting of: an electrode; a vessel configured to deliver cryogenic energy; a laser diode; an optical fiber configured to deliver ablative energy; a microwave energy delivery element; an ultrasound energy delivery element; a drug or other agent delivery element; and combinations thereof.

### Claim 18 (depends on 2)

The method according to claim 2, further comprising:
providing a sheath with a distal end; and
radially expanding the expandable assembly as it exits the sheath distal end.

### Claim 19 (depends on 2)

The method according to claim 2, wherein the plurality of electrodes comprises at least one electrode with an impedance of less than 10,000 ohms for frequencies above 0.1 Hertz.

### Claim 20 (depends on 2)

The method according to claim 2, wherein the plurality of ultrasound transducers comprises an assembly selected from the group consisting of: single or multi-element piezoelectric ceramics; piezoelectric micro-machined ultrasound transducers (pMUT); capacitive micro-machined ultrasound transducers (cMUT); piezoelectric polymers; and combinations thereof.

### Claim 21 (depends on 2)

The method according to claim 2, wherein each of the plurality of ultrasound transducers is disposed between two electrodes.

### Claim 22 (depends on 2)

The method according to claim 2, further comprising:
providing at least one body surface electrode;
delivering, with the distance measurement assembly, a signal to the at least one body surface electrode;
recording, with the distance measurement assembly, a second generated signal from the at least one body surface electrode; and
producing, with the distance measurement assembly, a second set of distance information based on the recording of the second generated signal.

### Claim 23 (depends on 2)

The method according to claim 2, wherein the three-dimensional anatomical map includes at least one of heart wall position information or heart wall thickness information.